Committed to Helping You Get Your Medicine
Knowing what to expect can make all the difference. We can help you
through each step of getting XOLAIR.
Frequently Asked Questions
About XOLAIR Access Solutions
What is XOLAIR Access Solutions?
XOLAIR Access Solutions is a resource for people who take XOLAIR. We
connect you to the medicine you need.
I Am Concerned About Paying for XOLAIR
My co-pays for XOLAIR are too high. How can you help me?
There may be options to help you get the XOLAIR your doctor has prescribed. XOLAIR Access Solutions can refer you to patient assistance options.
Where can I find information about the Genentech® Access to Care Foundation (GATCF)?
Getting My Medicine
How long will it take to get my medicine?
You might not be able to get XOLAIR right away. First, your doctor’s office or specialty pharmacy will have to check to make sure your health insurance plan covers your medicine. This is called a “benefits investigation.” They also might have to send some more information before your plan covers your medicine. This is called a “prior authorization.”
Enrolling in XOLAIR Access Solutions
How do I enroll in XOLAIR Access Solutions?
- You fill out a form called the PAN.
- You doctor fills out a form called the SMN. You do not have to fill out anything on this form.
- Your doctor sends both of these forms to XOLAIR Access Solutions.
There are 2 ways to fill out the PAN form:
- You can fill out the form online
- You can download and print it to fill out a paper copy
Why do I need to sign the PAN form?
The PAN form lets us discuss your health information with your doctor
and your health insurance plan. We can’t work with you without a
I submitted the PAN online or gave the signed PAN to my doctor. Is there anything else I need to do to enroll?
You do not need to do anything else, but your doctor does. He or she needs to submit a form called the SMN. The SMN tells us your doctor wants to treat you with XOLAIR. Make sure your doctor has sent us the SMN so you get help from us.
You do not need to fill out anything on the SMN form.
My Health Plan Denied Coverage for XOLAIR
My health insurance plan will not cover XOLAIR. What do I do?
If your health insurance plan will not cover XOLAIR, you and your
doctor's office can file an appeal. Contact your doctor to ask if you
should file an appeal.
We have resources to help you and your doctor file an appeal.
Does XOLAIR Access Solutions send the appeal to my health insurance care plan?
We have resources to help you and your doctor file an appeal. You or
your doctor’s office has to file the appeal directly with your health
How long does an appeal take?
This depends on your health insurance plan. You should ask your plan directly about its process. Sometimes the appeals process is quick. However, it can take several months if you have to appeal several times.
My Insurance Might Change
I am enrolled in XOLAIR Access Solutions and my health insurance plan has changed. What do I do next?
If your insurance changes while you're taking XOLAIR, call us. We can
help you understand your new coverage.
I no longer have a health insurance plan. What should I do?
The Genentech Patient Foundation gives free XOLAIR to people who
don't have insurance coverage or who have financial concerns and to
people who meet certain income criteria.
It is your and your doctor's responsibility to complete and submit
all required paperwork to your health insurance plan. Genentech and
Novartis Pharmaceuticals Corporation cannot guarantee your plan will
cover any treatments.
PAN=Patient Authorization and Notice of Request
for Transmission of Health Information to Genentech Access Solutions
and Genentech® Access to Care Foundation.
SMN=Statement of Medical Necessity.
Important Safety Information & Indication
What it Treats
What is XOLAIR?
XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat:
- moderate to severe persistent asthma in patients 6 years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens.
- chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamine treatment.
XOLAIR is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus.
Important Safety Information
What is the most important information I should know about XOLAIR?
Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:
- wheezing, shortness of breath, cough, chest tightness, or trouble breathing
- low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
- flushing, itching, hives, or feeling warm
- swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing
Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after your injection. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction after leaving the healthcare provider’s office or treatment center.
Do not receive XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.
Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:
- have a latex allergy or any other allergies (such as food allergy or seasonal allergies). The needle cap on the XOLAIR prefilled syringe may contain latex.
- have sudden breathing problems (bronchospasm)
- have ever had a severe allergic reaction called anaphylaxis
- have or have had a parasitic infection
- have or have had cancer
- are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive XOLAIR.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
How should I receive XOLAIR?
- XOLAIR should be given by your healthcare provider, in a healthcare setting.
- XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
- In asthma patients, a blood test for a substance called IgE must be performed prior to starting XOLAIR to determine the appropriate dose and dosing frequency.
- In patients with chronic hives, a blood test is not necessary to determine the dose or dosing frequency.
- Do not decrease or stop taking any of your other asthma or hive medicine unless your healthcare providers tell you to.
- You may not see improvement in your symptoms right away after XOLAIR treatment.
What are the possible side effects of XOLAIR?
XOLAIR may cause serious side effects, including:
- See, “What is the most important information I should know about XOLAIR” regarding the risk of anaphylaxis.
- Cancer. Cases of cancer were observed in some people who received XOLAIR.
- Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs.
- Fever, muscle aches, and rash. Some people who take XOLAIR get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider.
- Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection.
- Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether this is caused by XOLAIR.
The most common side effects of XOLAIR:
- In adults and children 12 years of age and older with asthma: pain especially in your arms and legs, dizziness, feeling tired, skin rash, bone fractures, and pain or discomfort of your ears.
- In children 6 to less than 12 years of age with asthma: common cold symptoms, headache, fever, sore throat, pain or discomfort of your ear, abdominal pain, nausea, vomiting and nose bleeds.
- In people with chronic idiopathic urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.
These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at 888-669-6682.